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Acute Lymphoblastic LeukemiaPhase 1/2MITCLNCT01842672

Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia

A Phase 1/2 study testing Clofarabine and Mitoxantrone in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by New York Medical College at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The combination of mitoxantrone and clofarabine as reinduction therapy will be safe, well tolerated and effective in children, adolescents and young adults with poor risk refractory/relapsed acute leukemia and high grade non-Hodgkin lymphoma (NHL). Read more about this study

Who is it for?
Ages Up to 30 years
What is being tested?
Clofarabine and Mitoxantrone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesUnited States
Study dates
Mar 2013to Sep 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age ≤30.99 years old
  • Disease Status (Part A - Safety Phase)
  • ALL in 1st, 2nd or 3rd relapse OR primary induction failure.
  • AML in 1st ,2nd or 3rd relapse OR primary induction failure.
  • T-or B -- Lymphoblastic Lymphoma (T-LBL, B-LBL); Diffuse Large B-cell Lymphoma (DLBCL) or Burkitt Lymphoma/Leukemia in 1st, 2nd or 3rd relapse OR primary induction failure.
  • 5.1.2.2 (Part B - Efficacy Phase)
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  • ALL in 2nd or 3rd relapse OR primary induction failure.
  • AML in 2nd or 3rd relapse OR primary induction failure.
  • T-or B -- Lymphoblastic Lymphoma (T-LBL, B-LBL); Diffuse Large B-cell Lymphoma (DLBCL) or Burkitt Lymphoma/Leukemia in 1st, 2nd or 3rd relapse OR primary induction failure.
  • Adequate renal function defined as:
  • Normal Serum creatinine based on age or Creatinine clearance > 60 ml/min or >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
  • Adequate liver function defined as:
  • Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN
  • Adequate cardiac function defined as:
  • Shortening fraction >27% by echocardiogram, or
  • Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
  • Performance Status
  • For patients age 1-16 years, Lansky score of ≥60.
  • For patients > 16 years, Karnofsky score of ≥60.
  • Negative urine pregnancy test for females of child bearing age.
  • Prior Therapy - Patients are eligible if they have been treated with clofarabine, mitoxantrone, or a combination of both in the past. However, the maximal lifetime cumulative previous anthracycline dose should not exceed doxorubicin dose equivalent of 450 mg/m2 (see Table 1). Patients who received more than one anthracycline prior to study entry should have each individual agent cumulative dose converted to doxorubicin equivalent and added together (eg, a patient who received cumulative dose of Daunorubicin at 200 mg/m2 and Mitoxantrone 48 mg/m2 has a total doxorubicin dose equivalent of 358.6 mg/m2 (200 mg/m2 x 0.833 + 48 mg/m2 x 4).
  • Table 1. Anthracycline Conversion Agent Conversion Factor to Doxorubicin Dose Doxorubicin Multiply total dose x 1 Daunorubicin Multiply total dose x 0.833 Idarubicin Multiply total dose x 5 Mitoxantrone Multiply total dose x 4
  • Informed Consent
  • Patients or the patient's legally authorized guardian must be fully informed about their illness and the investigational nature of this protocol (including foreseeable risks and possible side effects), and must sign an informed consent in accordance with the institutional policies approved by the U.S. Department of Health and Human Services.

Who cannot join

  • Patients with prior myeloablative allogeneic stem cell transplantation <3 months prior to proposed enrollment on study and/or ≥Grade II active acute GVHD or extensive chronic GVHD.
  • Females who are pregnant (positive HCG) or lactating.
  • Karnofsky <60% or Lansky <60% if less than 16 years of age.
  • Age >30.99 years of age.
  • Patients with active CNS disease.
  • Any patient with uncontrolled infection prior to study entry.
  • Patients with Down syndrome are excluded.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Levine Children's Hospital

    Charlotte, North Carolina, 28204

  • New York Medical College

    Valhalla, New York, 10595

Other trials in United States

About this study

Official title: A Pilot Study of Mitoxantrone in Combination With Clofarabine (MITCL) in Children, Adolescents and Young Adults (CAYA) With Refractory/Relapsed Acute Leukemia or High Grade Non-Hodgkin Lymphoma

The combination of mitoxantrone and clofarabine as reinduction therapy will be safe, well tolerated and effective in children, adolescents and young adults with poor risk refractory/relapsed acute leukemia and high grade non-Hodgkin lymphoma (NHL).

Being tested
Clofarabine, Mitoxantrone
Keywords
pediatric non-hodgkins lymphoma, pediatric acute leukemia, clofarabine, mitoxantrone
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClofarabineDrug

    Also called Clolar™, Evoltra, NSC# 606,869, IND # 73,789

    Dose Escalation of Clofarabine

  • MitoxantroneDrug

    Also called Novantrone

Study groups in NCT01842672
Study groupRoleWhat they receive
Mitoxantrone/ClofarabineExperimentalClofarabine Dose escalation starting 20 mg/m2/d days 1-5 Mitoxantrone 12 mg/m2/d days 3-6. Rituximab in patient with CD20+ disease only 375 mg/m2 day 1, 8, 15. IT Depocyt 35 or 50 mg/dose day 1 per cycle. IT ARA-C in children < 3 years age based dosing.
Receives: Drug: Clofarabine; Drug: Mitoxantrone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine MTD

    2.1 To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL.

    Measured: 100 days

Secondary outcomes (2)

  1. Response Rate

    To determine the overall complete and partial response rate (OR) of the combination of mitoxantrone and clofarabine as reinduction therapy for children, adolescents and young adults with refractory/relapsed acute leukemia or high grade NHL.

    Measured: 1 year

  2. Monitor for Minimal Residual Disease

    To determine the percent of minimal residual disease (MRD) in the peripheral blood following reinduction with mitoxantrone and clofarabine reinduction therapy.

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionAug 2021
  4. Study completionSep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842672
Sponsor's protocol ID
NYMC 542
Other IDs
L 10, 819
Acronym
MITCL
Status last verified
Oct 2022
First submitted
22 Apr 2013
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • Hochberg J, Oesterheld J, Gardenswartz A, Flower A, Klejmont L, Basso J, Shi Q, Harrison L, Borowitz MJ, Loken MR, Cairo MS. Mitoxantrone in combination with clofarabine (MITCL) in children, adolescents and young adults with relapsed/refractory acute leukaemia: final results of a phase I/II trial. EClinicalMedicine. 2025 Apr 28;83:103211. doi: 10.1016/j.eclinm.2025.103211. eCollection 2025 May.

    PubMed 40641817

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Clofarabine and Mitoxantrone in people with Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia, run by New York Medical College at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine MTD (time frame: 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01842672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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